Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

A day be­fore its sec­ond an­nu­al Vac­cines Day, Mod­er­na has post­ed an up­date on its crown jew­el, in­clud­ing a 6-month look at the Covid-19 shot and new pre­clin­i­cal da­ta that sug­gest its boost­er can­di­dates stand a fight­ing chance against new vari­ants.

Mod­er­na’s vari­ant-spe­cif­ic boost­er mR­NA-1273.351, which was de­signed to tar­get the B.1.351 mu­ta­tion first iden­ti­fied in South Africa, “closed the neu­tral­iz­ing titer gap for vari­ants of con­cern” in mice, the com­pa­ny said on Tues­day af­ter­noon. When giv­en at the 6-month mark, the boost­er elicit­ed neu­tral­iz­ing titers against the vari­ant that were com­pa­ra­ble to those pro­duced against the orig­i­nal virus.

mR­NA-1273.211, a com­bi­na­tion of mR­NA-1273.351 and Mod­er­na’s al­ready au­tho­rized vac­cine, al­so in­creased neu­tral­iz­ing titers against vari­ants ac­cord­ing to the pre­clin­i­cal re­sults, which have been sub­mit­ted to bioRx­iv but haven’t been pub­lished.

“The new pre­clin­i­cal da­ta on our vari­ant-spe­cif­ic vac­cine can­di­dates give us con­fi­dence that we can proac­tive­ly ad­dress emerg­ing vari­ants,” CEO Stéphane Ban­cel said in a state­ment. “Mod­er­na will make as many up­dates to our COVID-19 vac­cine as nec­es­sary un­til the pan­dem­ic is un­der con­trol.”

Ban­cel told End­points News that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, be­cause a lot of peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. Then in 2023 or 2024, he pre­dicts the speed at which the vac­cine mu­tates could slow down.

“We think that in the next two years, there might be a need for sev­er­al boosts, es­pe­cial­ly for peo­ple at high risk,” he said. “We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts.”

As for the orig­i­nal vac­cine, an up­dat­ed re­view of 900-plus Covid-19 cas­es from the Phase III COVE study con­firms the jab is more than 90% ef­fec­tive against all cas­es, and over 95% ef­fec­tive against se­vere cas­es. A study with 33 Phase I par­tic­i­pants showed that an­ti­bod­ies per­sist­ed 6 months af­ter the sec­ond dose, ac­cord­ing to re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine. Mod­er­na be­lieves ef­fi­ca­cy kicks in two weeks af­ter the sec­ond dose.

As part of its own up­dat­ed re­view, Pfiz­er said its BioN­Tech-part­nered jab demon­strat­ed “strong pro­tec­tion” 6 months af­ter the sec­ond dose, with an over­all ef­fi­ca­cy rate of 91.3%.

Mod­er­na’s Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US, ac­cord­ing to the com­pa­ny. That tri­al will as­sess a 100 µg dose of the vac­cine. Mean­while, the Phase II/III Kid­COVE study is still re­cruit­ing chil­dren be­tween 6 months and 11 years old. Mod­er­na hopes to en­roll 6,750 healthy par­tic­i­pants in the US and Cana­da for the two-part dose es­ca­la­tion study. In Part 1, chil­dren be­tween the ages of 2 and 12 will re­ceive ei­ther 50 μg or 100 μg of the vac­cine, and those who are younger will be giv­en one of three dose lev­els — 25 μg, 50 μg or 100 μg. An in­ter­im analy­sis will de­ter­mine which dose is used in Part 2.

The news comes as the US paus­es the roll­out of J&J’s vac­cine to re­view da­ta around six re­port­ed cas­es of a rare and se­vere type of blood clot. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is meet­ing to­mor­row to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance.

The EMA re­port­ed 3 cas­es of cere­bral ve­nous si­nus throm­bo­sis among the 4.5 mil­lion peo­ple vac­ci­nat­ed with J&J’s shot world­wide. By com­par­i­son, 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed among 34 mil­lion peo­ple who re­ceived the As­traZeneca vac­cine in the EEA and UK. Thir­ty-five CVST cas­es were found world­wide among those who have re­ceived the Pfiz­er shot, and 5 for Mod­er­na.

“A com­pre­hen­sive as­sess­ment of the to­tal­i­ty of the avail­able safe­ty da­ta for mR­NA-1273 af­ter over 64.5 mil­lion dos­es ad­min­is­tered glob­al­ly does not sug­gest an as­so­ci­a­tion with CVST or throm­bot­ic events, based on analy­ses per­formed us­ing da­ta through March 22, 2021,” Mod­er­na said in a state­ment.

The CDC has is­sued a state­ment that its Vac­cine Ad­verse Event Re­port­ing Sys­tem “has re­ceived no re­ports of CVST with throm­bo­cy­tope­nia among per­sons who re­ceived ei­ther of the two mR­NA-based COVID-19 vac­cines.”

As of April 12, Mod­er­na had shipped out 132 mil­lion dos­es world­wide, in­clud­ing about 117 mil­lion to the US. Rough­ly 88 mil­lion dos­es were de­liv­ered to the US in Q1, in ad­di­tion to about 14 mil­lion else­where. Plans are in place to ramp up the com­pa­ny’s ex-US sup­ply chain.

Mod­er­na says it’s on track to de­liv­er 100 mil­lion dos­es to the US by the end of May, and an­oth­er 100 mil­lion by the end of Ju­ly.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.